Data from Pharmawand - Curated by EPG Health - Date added 12 June 2018

Tetraphase Pharmaceuticals recently reported data on eravacycline, which is currently under review by the FDA and the EMA for the treatment of complicated intra-abdominal infections (cIAI) at the American Society for Microbiology (ASM) Microbe 2018 Annual Meeting. This is the first post-hoc analysis of IGNITE1 and IGNITE4 – two of the Investigating Gram-Negative Infections Treated with Eravacycline (IGNITE) phase III trials for eravacycline. IGNITE1 and IGNITE4 were randomized, double-blind, double-dummy, multi-center studies assessing the efficacy and safety of intravenous (IV) eravacycline compared to ertapenem and meropenem, respectively, in patients with cIAI. IGNITE1 included 541 patients and used a 10% non-inferiority margin, while IGNITE4 included 500 patients and used a 12.5% non-inferiority margin. Both IGNITE1 and IGNITE4 met the primary endpoints of clinical cure with eravacycline achieving high cure rates in patients with Gram-negative and Gram-positive pathogens, including resistant isolates.

The primary objective of the pooled analysis was to compare the clinical and microbiological responses at the test-of-cure (TOC) visit for subjects in the two treatment groups, with an emphasis on the response of MDR pathogens to eravacycline. For patients with cIAI caused by Enterobacteriaceae, the overall favorable clinical and microbiological response rates among pooled eravacycline-treated subjects were 88.2% and 86.3%, respectively. Notably, in patients with infections due to ESBL-producing Enterobacteriaceae, eravacycline demonstrated a favorable microbiologic response rate of 88.9%. For patients with cIAI caused by A. baumannii, of which most strains were MDR, the overall favorable clinical and microbiological response rate among pooled eravacycline-treated subjects was 100%.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Inflammatory Bowel Disease Knowledge Centre

Inflammatory Bowel Disease Knowledge Centre

The Inflammatory Bowel Disease (IBD) Knowledge Centre contains key information relating to the epidemiology and pathophysiology of Crohn’s disease and ulcerative colitis, highlighting prevalence, impact and unmet needs and the underlying inflammatory processes that drive IBD, considering some of the key inflammatory pathways.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Load more

Related Content